Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

96 results found

Title
Status

 

VICTORY (OZM-138) - VICTORY: A Pilot Study to Investigate Safety and Efficacy of Weekly Combination of Intravenous Vinblastine With Oral Type II RAF Inhibitor Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas

Open

VICTORY (OZM-138) - VICTORY: A Pilot Study to Investigate Safety and Efficacy of Weekly Combination of Intravenous Vinblastine With Oral Type II RAF Inhibitor Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas

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DiagnosisLow-grade GliomaStudy StatusOpen
PhaseI
Age0 Weeks to 25 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Tovorafenib oral (immediate-release tablets or powder for reconstitution) Drug: Vinblastine IV
Last Posted Update2024-05-10
ClinicalTrials.gov #NCT06381570
International Sponsor
IIT - The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Uri Tabori
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

VICTORY is an early phase study for patients under 25 years who have a type of brain tumor called low grade glioma (LGG) that coms back or gets worse (recurrent or progressive). To participate on this study, the LGG must have certain genetic changes called CRAF or BRAF alterations.

The study has two parts:

Phase A: We are figuring out the best dose of a combination of two medicines, vinblastine and tovorafenib. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Phase B: After we find the right dose in Phase A, we'll test how well the combination of these drugs works. Patients will take these medicines for a certain number of months, then just tovorafenib for a few more months. Their progress will be checked regularly with scans.

Patients will be in the study for about two years unless their tumor gets worse (disease progression), they have bad side effects or they decide to withdrawal from the study.

Inclusion Criteria
  • Patients must be less than or equal to 25 years of age at the time of enrollment
  • Patient and/or their parent/guardian must sign an informed consent form to be enrolled on study
  • Patients must have a diagnosis of low grade glioma (LGG) with a genetic alteration called BRAF or CRAF alteration that has come back (recurrent) or not responded to previous treatment (progressive)
  • Patients must have completed at least 1 other therapy prior to enrollment on this study and recovered from its effects.
  • Patients must have adequate performance status (daily activities which they are able to do) 
  • Must have adequate organ function in bone marrow, kidneys, liver, heart and thyroid
  • Willingness of male and female patients with reproductive potential to use double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 180 days following the last dose of study drug. 
  • Ability to swallow tablets or liquid, or gastric access via a nasal or gastric tube.

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

Closed to enrollment

HeadStart4 (IRB15-00399) - HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue

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DiagnosisMedulloblastoma, Central Nervous System Embryonal Tumors, Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastomaStudy StatusClosed to enrollment
PhaseIV
AgeChild - (up to 10 years)RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationIV chemotherapies
Last Posted Update2024-05-02
ClinicalTrials.gov #NCT02875314
International Sponsor
Nationwide Children's Hospital
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. Sylvia Cheng
Alberta Children's Hospital – Dr. Lucie Lafay-Cousin
The Hospital for Sick Children – Dr. Annie A. Huang
Stollery Children's Hospital – Dr. Bev Wilson
Hamilton Health Sciences Centre, McMaster University – Dr. Adam Fleming

Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 

 

 

Study Description

This study looks to assess if additional intensive treatment for patients with medulloblastoma and other embryonal brain tumors improves outcomes without adding significant short or long-term side effects. 

Inclusion Criteria

Patients 10 years of age of less with a diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord. Any stage of medulloblastoma or CNS embryonal tumor in children less than 6 years old are eligible, whereas only high risk patients from 6-10 years of age are eligible. 

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

I3Y-MC-JPCS - A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

Suspended

I3Y-MC-JPCS - A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

Go to Health Care Provider version

DiagnosisSolid TumorStudy StatusSuspended
PhaseI/II
Ageup to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationAbemaciclib (Given Orally) in combination with: Irinotecan and Temozolomide (Part A Only) Temozolomide alone (Part B Only) Dinutuximab, GM-CSF, Irinotecan, and Temozolomide (Part C Only)
Last Posted Update2024-05-02
ClinicalTrials.gov #NCT04238819
International Sponsor
Eli Lilly and Company
Principal Investigators for Canadian Sites
Ste Justine - Dr. Pierre Teira
Centres
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment.

Inclusion Criteria
  • Participants must be ≤ 18 years of age (Part A and B only) or < 21 years of age (Part C only)
  • Must have adequate body surface area (BSA)
  • Participants must have a solid tumour (excluding lymphoma) that has come back or progressed on standard therapies
  • PART C ONLY: Participants with neuroblastoma that has come back or progressed on standard therapies
  • Participants must be able to be up and about for at least half of their waking hours
  • Participants of reproductive potential must not be pregnant within 7 days of and during the study
  • Ability to swallow
  • Participants and their families (as applicable) must agree to the study assessments by signing an informed consent form

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Open

AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

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DiagnosisAnaplastic Wilms Tumor, Recurrent Wilms TumorStudy StatusOpen
PhaseII
Ageup to 30 YearsRandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationChemotherapy medications, all given intravenously (Carboplatin, Cyclophosphamide, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Topotecan, Vincristine)
Last Posted Update2024-04-30
ClinicalTrials.gov #NCT04322318
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor Lewis
BC Children's Hospital - Dr. David Dix
CancerCare Manitoba - Dr. Ashley Chopek
McMaster Children's Hospital - Dr. Uma Athale
Stollery Children's Hospital - Dr. Sarah McKillop
Western Children's Hospital - Dr. Shayna Zelcer
Children's Hospital of Eastern Ontario (CHEO) - Dr. Donna Johnston
Hospital for Sick Children - Dr. Daniel Morgenstern
Montreal Children's Hospital - Dr. Sharon Abish
CHU Quebec - Dr. Bruno Michon
CHU Ste. Justine - Dr. Yvan Samson
IWK Health Centre - Dr. Craig Erker
Janeway Hospital - Dr. Lisa Goodyear
CHU Sherbrooke - Dr. Josée Brossard
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
Medical contact
Dr. Josee Brossard 
Social worker/patient navigator contact
Please Contact Site Directly
 
Clinical research contact
Please Contact Site Directly 
 

 

 

Study Description

In this study, researchers want to find out if

  • they can improve treatment for participants with newly diagnosed diffuse anaplastic Wilms tumour (DAWT). In hopes of finding a better therapy to fight against the cancer, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight against cancer and together, the treatment is known as Regimen UH-3. This study looks at how well Regimen UH-3 works when given to children and young adults with newly diagnosed DAWT.
  • they can improve treatment for participants with "standard risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed). In hopes of finding a better therapy to fight against the cancer, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight against cancer and together, the treatment is known as Regimen UH-3. This study looks at how well Regimen UH-3 works when given to children and young adults with "standard risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed).
  • they can improve treatment for participants with "high-risk or very high-risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed). In hopes of finding a better therapy to fight against the cancer you have, participants will be given chemotherapy drugs and radiation therapy in this study. The chemotherapy drugs that participants will be receiving are often given to fight cancer and together, the regimen is known as Regimen ICE/Cyclo/Topo. This study looks at how well this regimen works when given to children and young adults with "high-risk or very high-risk" favourable histogy Wilms tumour (FWHT) that has come back (relapsed).

Drugs used in chemotherapy regimens work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

 

Inclusion Criteria
  • Age less than 30 years
  • New diagnosis of diffuse anaplastic Wilms tumour
  • OR a diagnosis of Wilms tumour at first relapse (tumour that has come back, and must have been "favourable histology" at initial diagnosis)
  • Patient must be capable of all self care - such that they are out of bed >50% of day
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Open

AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

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DiagnosisHepatocellular Carcinoma, Malignant Liver Neoplasm, Fibrolamellar Carcinoma, Hepatoblastoma Study StatusOpen
PhaseII/III
AgeChild, Adult - (up to 30 Years)RandomisationYES
Line of treatmentFirst line treatment
Routes of Treatment AdministrationCisplatin: IV, Other drugs are given as usually administered for hepatoblastoma/liver cancer therapy
Last Posted Update2024-04-30
ClinicalTrials.gov #NCT03533582
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor A. Lewis
University of Alberta Hospital (Not Affiliated with U-Link) - Dr. Sarah J. McKillop
CancerCare Manitoba - Dr. Ashley Chopek
IWK Health Centre - Dr. Craig Erker
Hamilton Health Sciences Centre, McMaster University - Dr. Uma H. Athale
Cancer Centre of Southeastern Ontario at Kingston General Hospital - Dr. Laura Wheaton
Children's Hospital of Western Ontario - Dr. Shayna M. Zelcer
The Hospital for Sick Children - Dr. Furqan Shaikh
Montreal Children's Hospital - Dr. Sharon B. Abish
CHU Ste-Justine - Dr. Yvan Samson
CHU de Quebec - Dr. Bruno Michon
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez 
Dr. Ketan Kulkarni 
 
Social worker/patient navigator contact
Rhonda Brophy
 
Clinical research contact
Tina Bocking
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Dr. Laura Wheaton
Dr. Mariana Silva
 
Social worker/patient navigator contact
Jessica Amey
 
Clinical research contact
Heather McLean
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

 

 

Study Description

This trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.


Inclusion Criteria
  • Patients must be newly diagnosed with hepatic malignancies (liver cancers) such as hepatoblastoma or hepatocellular carcinoma
  • Patients must be under 30 years of age 
  • All patients and/or their parents or legal guardians must sign a written informed consent

ONITT - A Randomized Phase I/II Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

Closed to enrollment

ONITT - A Randomized Phase I/II Study of Talazoparib or Temozolomide in Combination With Onivyde in Children With Recurrent Solid Malignancies and Ewing Sarcoma

Go to Health Care Provider version

DiagnosisEwing Sarcoma, Hepatoblastoma, Neuroblastoma, Osteosarcoma, Rhabdoid Tumor, Rhabdomyosarcoma, Wilms, SarcomaStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (12 Months to 30 Years) RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOnivyde: IV , Talazoparib: oral , Temozolomide: unspecified (oral or IV most likely)
Last Posted Update2024-04-26
ClinicalTrials.gov #NCT04901702
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
BC Children's Hospital - Dr. Rebecca Deyell
CHU Ste Justine - Dr Monia Marzouki
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This study seeks to test the effectiveness and best dosage for 2 different combinations of drugs in treating cancers that have come back (recurring) or never completely went away (refractory) after initial treatment. Participants will be randomly assigned to either Arm A or Arm B of the study which will determine the combination of drugs they receive.

In Arm A, participants will receive drugs called Onivyde and talazoparib.

In Arm B, participants will receive drugs called Onivyde and temozolomide.

Both combination of drugs (Onivyde + talazoparib or Onivyde + temozolomide) are expected to irreparably damage the DNA in cancer cells and lead to cancer cell death.

After the best dosages of the drug combinations are determined in Arm A and Arm B, then the study will move on to the next stage called “expansion arms”. These expansion arms treat more participants with the dosages determined in the earlier Arm A and Arm B.

There are 3 expansion arms in this study:

Arm A1: Participants with Ewing sarcoma that has come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and talazoparib.

Arm A2: Participants with cancers that have come back (recurring) or never completely went away (refractory), and their cancer has a problem with repairing DNA (identified by their doctor) will receive drugs called Onivyde and talozoparib.

Arm B1: Participants with cancers that have come back (recurring) or never completely went away (refractory) will receive drugs called Onivyde and temozolomide.

 

Inclusion Criteria
  • Participants must be > 12 months and <30 years at the time of enrollment
  • Diagnosed with cancers that have come back (recurring) or never completely went away (refractory)
  • Female or male participant of reproductive potential must agree to use effective contraceptive methods at screening and throughout duration of study treatment.
  • Female participants who have begun to menstruate must have a negative urine or serum pregnancy test and must be willing to have additional serum and urine pregnancy tests during the study
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

Completed

PED-CITN-01 - 3CI Study: Childhood Cancer Combination Immunotherapy.

Go to Health Care Provider version

DiagnosisLymphoma, brain tumours except diffuse intrinsic pontine glioma, solid tumoursStudy StatusCompleted
PhaseI
AgeChild, Adult - (1 to 25 Years) RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2024-04-10
ClinicalTrials.gov #NCT04500548
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern


Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study

This study investigates the side effects of the combination of two immunotherapy medications called nivolumab and ipilimumab, and to see how well they work in treating children, adolescents and young adults with cancers that have come back (relapsed) or does not respond to treatment (refractory) and have an increased number of genetic changes. Immunotherapy with nivolumab and ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

This study is being done to help doctors learn if the combination of nivolumab and ipilimumab can help children, adolescents, and young adults patients live longer.

This study will have two parts

  • PART I: A tissue sample from the tumour is analysed for "tumour mutation burden" level. Patients with elevated level may be eligible for Part II.
  • PART II: Patients receive receive treatment with nivolumab or nivolumab and ipilimumab.

 

Inclusion Criteria
  • Age from 12 months to 25 years
  • Patient with a cancer that has come back (relapsed) or does not respond to treatment (refractory)
  • All tumours can be considered except leukemia and diffuse intrinsic pontine glioma
  • The tumour will be tested (part 1). It needs to to have an increased number of genetic changes for the patient to be considered for part 2
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

ADP 0044-002 - A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Open

ADP 0044-002 - A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

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DiagnosisSynovial Sarcoma, Myxoid Liposarcoma, Round Cell LiposarcomaStudy StatusOpen
PhaseII
Age10 Years to 75 Years RandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationGenetic: afamitresgene autoleucel (previously ADP-A2M4) Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT04044768
International Sponsor
Adaptimmune
Principal Investigators for Canadian Sites
Princess Margaret Cancer Centre - Dr. A. Razak
Centres
Medical contact

    CNS - Dr. Julie Bennett

     julie.bennett@sickkids.ca

     Sarcoma - Dr. Abha Gupta

     abha.gupta@uhn.ca

     Leukemia & Lymphoma - Dr. Dawn Maze

     dawn.maze@uhn.ca

Social worker/patient navigator contact

Please contact medical team for further information.

Clinical research contact

     CNS Trials - On Yee Jones

     onyee.jones@uhn.ca

     Sarcoma Trials - Hagit Peretz Soroka

     hagit.peretz@uhn.ca

     Leukemia & Lymphoma Trials - Deborah Sanfelice 

     deborah.Sanfelice@uhn.ca

 

 

Study Description

This study is to investigate how effective and safe the use of SPEAR™ T cells is in patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma.

Inclusion Criteria
  • Age ≥16 (10 years at selected sites) and <=75 years
  • Diagnosis of advanced synovial sarcoma or myxoid liposarcoma / myxoid round cell liposarcoma with the appropriate genetic marker
  • Measurable disease
  • Adequate performance status (patient's level of functioning) 

Note: other protocol defined Inclusion criteria may apply and will be discussed with you by the study team.

Publications

A kinase-cGAS cascade to synthesize a therapeutic STING activator - PubMed (nih.gov)